Clinique Maussins-Nollet
Paris, 75019, France
NCT Number: NCT05014932
Evaluation of noise induced by ceramic-ceramic friction torques of total hip prostheses with customized femoral stem.
Retrospective and prospective multicentric study.
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Notify Me18 year and older
All sexes
Observational
Paris, 75019, France
On a series of patients operated on for more than two years after a total hip arthroplasty that resulted in the implantation of a ceramic-on-ceramic prosthesis with a customized femoral stem:
Primary objective: To assess the frequency of occurrence of joint noise.
Secondary objectives:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 2 years
Percentage of occurrence of noise nuisance (assessed in relation to the total number of patients and the total number of prostheses).
The frequency of occurrence of noise nuisance will be analysed descriptively. The time elapsed until the occurrence of the noise nuisance will be additionally assessed by a Kaplan-Meier analysis.
Time frame: 2 years
The Oxford Hip Score questionnaire (OHS 12) consists of 12 questions. It measures pain (6 items) and hip function (6 items) in relation to activities of daily living such as walking, dressing and sleep disturbance. Each question has 5 possible answers. Each has a value from 0 to 4, with 0 representing the highest level of severity and 4 representing no or almost no symptoms.
Time frame: 2 years
The HOOS questionnaire is a self-administered questionnaire specific to hip arthroplasty. It consists of 40 questions with 5 domains: 5 questions on symptoms and stiffness; 10 questions on pain; 17 questions on functional results in daily life; 4 questions on sport and leisure activities; 4 questions on quality of life.
It includes 5 sub-scores, one sub-score per domain.
Time frame: 2 years
The Forgotten Joint Score (FJS-12) is a self-administered questionnaire consisting of 12 questions assessing the degree of forgetfulness of hip replacements in a given situation of daily life. Each answer is selected from a 5-point Likert scale with response options ranging from never (0) to most of the time (4).
Time frame: 2 years
The life span of the prosthesis is the time between the implantation of the prosthesis and its complete or partial surgical revision.
GCS Ramsay Santé pour l'Enseignement et la Recherche
Other
Acronym: ATHENS
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